Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.

Recall Number: D-1405-2019

Firm: Synthetopes Inc

Classification: Class II

Status: Terminated

Report Date: 20190619

Initiation Date: 20190528

Termination Date: 20201015

Reason for Recall

Lack of Processing Controls.

Product Description

Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.